Azra Rajwani

Pros and Cons of Virtual Audits

Onsite or Virtual AuditsOver the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public.
Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted from onsite audits to virtual audits, with many certification bodies offering virtual audits as an option moving forward even with the economy re-opening.

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Tara Lysechko

Update on Health Canada Activities and Changes

Health Canada Regulatory Development UpdateKeeping current with Health Canada’s medical device regulatory developments

Over the course of the last year and a half, the number of accomplishments that Health Canada has achieved both in urgent response to the COVID-19 pandemic and towards priority projects is impressive.
It has been said that timing is everything. While the operational pressures from COVID-19 affected proposed timelines and milestones for regulatory framework innovation, the pandemic also provided an opportunity to test temporary agile regulatory measures.
These measures provided an important proof of concept for ideas that were already under consideration and reinforced the need for regulatory agility to support timely access to needed health products. The lessons learned from the regulatory response to the pandemic will therefore form an integral part of Health Canada’s future regulatory innovation efforts.

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Arash Samimi

Why Medical Device Startups Should Listen to The Ecosystem

A Three-Pronged Strategy to Stay Ahead

Listening Strategy for Startups
A medical device is a convergence point where various technologies and regulations come together to impact patient health. Within the diverse ecosystem of the medical device industry, there are fluctuations driven by new entrants, new technologies and new markets. These forces create market shifts and open up opportunities. KPMG has published an interesting whitepaper on the subject.

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Deborah Pinchev

Using Medical Device Symbols

Key updates in ISO 15223-1:2021

ISO 15223-1:2021 Symbols UpdateSymbols are a universal language. When looking at smiley and sad faced emojis anyone from around the world can differentiate the meaning between the two. That is the power of symbols.
In the right context symbols can convey a significant amount of information in a small amount of printed or digital space. That is why they are valued and encouraged for use as part of medical device labelling. In September 2016, the FDA began permitting symbols without the need for adjacent explanatory text as long as a glossary is provided in accompanying documentation.

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Aaron Philippsen

Three Physical Connection Methods in Medical Device Test Fixtures

3 Physical Connection Methods in Medical Device Test FixturesPhysical testing is an essential tool for product development, particularly when developing a novel medical device. When well designed, a physical test can accurately represent phenomena that are difficult to model, and physical tests can often be constructed quickly with a minimum of custom components.
Here are three connection methods that I have found useful for physical testing fluid connections in medical device test fixtures. Of the many options, these connection methods are readily available, inexpensive, and well suited for low pressure physical testing. I generally use them for tests involving a small number of test runs, fluids similar to water, and pressures near 1atm.

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Megan Griffin

Five Considerations for Successful Onboarding

Considerations for Successful OnboardingEnsuring new hires feel connected to the team and engaged in their position is critical. So much has changed since moving to remote work, including the onboarding process. Don’t be fooled; the initial weeks or months aren’t just when an organization assesses their new hire, it’s also for the new employee to determine if they will be able to thrive within their new team.

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Azra Rajwani

Returning to Work Safely During COVID

Returning to Work Safely
I think it’s safe to say that returning to work is going to look very different in a post-pandemic life. Or what we are now calling the ‘new normal’. Many of us are now used to working in our pajamas and rolling right out of bed into our desk, but we will eventually have to get back into the office. How can we do that safely, without the lingering fear of the ever-lurking COVID-19 virus?

 

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Joris van der Heijden

Developing a Diagnostic Product for Use Outside a Laboratory

The COVID-19 pandemic has increased diagnostic testing outside the confinement of the laboratory. The hope is to enable healthcare professionals to perform testing in places where it was previously unthinkable to sample patients and directly analyze test results. Such places now include your home, airports, or the workplace. These innovative solutions greatly reduce the time to get a test result and are revolutionizing diagnostic screening. This blog outlines some of the considerations that go into developing a diagnostic product intended for use outside a traditional laboratory.

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Ryan Field

Microfluidic Optics in Diagnostic Platforms

Applications of Optics in Microfluidic Diagnostic Platforms
This blog discusses implementation of optics in microfluidics systems including: Ways that lenses can be implemented on microfluidic cartridges; an overview of optical detection techniques used in microfluidics systems; and methods used in measuring fluorescence on microfluidic platforms.
Optical systems play an important role in microfluidic platforms. Such systems are the most reliable apparatuses for measuring the outputs of assays on microfluidic cartridges.

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